Updated FDA Black Box Warning for Fluoroquinolone Antibacterial Drugs

Achilles-tendon-ruptureThe FDA revised the Boxed Warning, its strongest warning, about fluoroquinolone antibacterial drugs to address side effects including permanent damage to the tendons, muscles, joints, nerves, and central nervous system — which can occur together in the same patient.

On July 26, 2016, the FDA identified the specific drugs:

  • Avelox (moxifloxacin)
  • Cipro (ciprofloxacin)
  • Cipro extended-release (ciprofloxacin extended-release)
  • Factive (gemifloxacin)
  • Levaquin (levofloxacin)
  • Ofloxacin (generic brand)

The Fluroroquinolones MDL 2642, which includes complaints related to Levaguin, Cipro and Avelox related to peripherial neruropathy have been transfered to the same court (District of Minnesota) and the same Judge (John R Tunheim) as the Levaquin MDL 1943 related to tendon ruptures.

Cases Pending

 

For an update, read:

After Science Day, Flouroquinolone Litigation Heads Toward Settlement

Defense counsel reported that there are currently 18 cases pending in the MDL. The DeFelice case is active and in the process of discovery. The Watson case is settled and paperwork is being prepared for dismissal. Ten other cases are waiting for paperwork and will soon be ready for dismissal. Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

With regard to the remaining two cases, Castillo and Ditolla, defense counsel did not hear back from plaintiffs’ counsel. The Court agreed that defense counsel should prepare the papers for orders to show cause and submit them to the Court.

Defense counsel reported that in six pending cases, the parties previously reached a settlement, but defense counsel never received final paperwork. Defense counsel sent plaintiffs’ counsel letters requesting that they attend the next status conference. In four out of the six cases, defense counsel successfully made contact with counsel for the plaintiffs, and they hoped to finalize the paperwork soon.

Remand/Transferred Cases

Defense counsel reported that of the cases transferred or remanded 52 had settled, 19 were dismissed, and 19 remained open.

In the Tummolo Case, Plaintiff’s counsel Jacqueline Olson stated that a few years ago certain documents were not sent to the defendants, which resulted in dismissal. Olson says =that she would like the case put back on active calendar and intended to apply to have the case restored.

Defense counsel Tracy Van Steenburgh and Cort Sylvester said that the case is currently dismissed and that Plaintiff would need to file a motion to vacate the dismissal, which defense counsel would decide whether to oppose. The Court stated that plaintiff should file a motion to vacate with supporting reasons within the next two weeks, after which the defense counsel would have an opportunity to respond.

Black Box Warning

The FDA also updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

The agency is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.

The labels of fluoroquinolone medicines already have:

  • A Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis.
  • Warnings about the risks of peripheral neuropathy and central nervous system effects.
  • Labels that warn of other serious risks such as cardiac, dermatologic, and hypersensitivity reactions.

After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, it evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone

FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see the List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication).

Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

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Ruining Lives with Xaretlo and Invokana, Johnson & Johnson Reports $18.5 Billion in Sales

xarelto internal-bleedingJohnson & Johnson announced sales of $18.5 billion on July 19, 2016 for the second quarter of 2016, an increase of 3.9% as compared to the second quarter of 2015 based on the financial success of two dangerous drugs — Xarelto, an anticoagulant, and Invokana, a type 2 diabetes therapy.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

In Q2, Xarelto sales jumped 26% year over year to $594 million. That performance will likely keep it as the second-best-selling drug in a class of next-generation anticoagulants known as factor Xa inhibitors, according to the Motley Fool. Factor Xa’s like Xarelto are taking away market share from Warfarin, which has been the dominant anticoagulant over the past 50 years, the investment website says.

While Xarelto’s growth remains strong, sales growth did slide slightly from 29% in Q1. The Motley Fool suggests that the factor Xa from Pfizer and Bristol-Myers Squibb, Eliquis, continues to win share more quickly than Xarelto. In Q1, Eliquis sales more than doubled year-over-year to $734 million.

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Feds Nail J&J Subsidiary in $18 Million Settlement of False Claims Charges

sinus medical device
Acclarent marketed the Stratus even after the FDA rejected the company’s 2007 request to expand the approved uses for it.

The U.S. Attorney’s Office in Boston announced on July 22, 2016, that medical device manufacturer Acclarent Inc., has agreed to pay $18 million to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal healthcare programs.

Acclarent — a subsidiary of Ethicon, a Johnson & Johnson company — marketed and distributed the sinus surgery device, the Relieva Stratus, for use as a drug delivery device without U.S. Food and Drug Administration (FDA) approval of that use.

Ethicon is a defendant in Transvaginal Mesh Litigation consolidated in MDL 2327 before Judge US District Court Judge Joseph R. Goodwin the Southern District of West Virginia.

“Marketing medical devices for other than FDA approved uses can expose patients to questionable medical treatments while asking taxpayers to pick up the Medicare cost,” said Special Agent in Charge Phillip M. Coyne of the Department of Health and Human Services Office of Inspector General.  “Our investigators, working closely with our law enforcement partners, will continue to pursue allegations of such misconduct and deter those tempted to launch such illegal scams.”

Marketing device after FDA rejection

Acclarent sold a variety of medical devices used in sinus surgeries, including a device known as the Relieva Stratus MicroFlow Spacer (Stratus).  In 2006, the company received FDA clearance to market the Stratus as a spacer to be used only with saline to maintain sinus openings following surgery.  The government alleged that Acclarent intended for the Stratus to be used instead as a drug-delivery device for prescription corticosteroids, including Kenalog-40, and that the device was specifically designed and engineered for this use.

The government also charged that Acclarent marketed the Stratus as a drug delivery device even after the FDA rejected the company’s 2007 request to expand the approved uses for the Stratus.  For example, Acclarent employees trained physicians using a video that demonstrated the Stratus being used with prescription corticosteroid Kenalog-40 and also used a white, milky substance resembling Kenalog-40 when demonstrating the Stratus.

In 2010, after the acquisition by Ethicon, Acclarent added a warning to its label regarding the use of active drug substances in the Stratus.  By May 2013, Acclarent discontinued all sales of the Stratus and the company agreed to withdraw all FDA marketing clearances for the device, which is no longer commercially available in the United States.  Ethicon also cooperated with the government’s investigation.

On Wednesday, July 20th, Acclarent’s former Chief Executive Officer, William Facteau, 47, of Atherton, California and former Vice President of Sales, Patrick Fabian, 49, of Lake Elmo, Minnesota were convicted of 10 misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce.

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Taxotere Chemo Drug Lawsuit Now filed in California Federal Court

taxotere hair loss
It is generally understood that temporary baldness may be a side effect of chemotherapy, women were not warned of the risk of permanent baldness.

Gomez Trial Attorneys of San Diego filed one of the first Taxotere chemotherapy drug lawsuits in a Southern California federal court yesterday on behalf of a woman who is suffering from its permanent effects (US District Court – Southern District of California Case No. 16CV1861).

The lawsuit alleges that the drug’s manufacturer, Sanofi-Aventis, failed to disclose and warn women and their doctors of Taxotere®’s increased risk of permanent baldness (alopecia) following chemotherapy.

The case is the latest in a string of over 30 cases filed across the country against the French drug manufacturer. Gomez says his firm plans to file more cases to hold the manufacturer accountable for its actions. Defendants include Sanofi S.A., Aventis Pharma S.A. and Sanofi-aventis U.S. LLC.

“While our clients battled and survived breast cancer, they now must live out their lives with a disfiguring reminder of what they went through. When they were in crisis and most vulnerable, they were robbed of the opportunity to make an informed decision about their healthcare,” says John Gomez, founder and CEO of Gomez Trial Attorneys.

Permanent baldness

While it is generally accepted and understood that temporary baldness may be a side effect of chemotherapy, women were not warned of the risk of permanent baldness despite an alternative and equally effective drug being available.

In 1996 the US Food and Drug Administration (FDA) approved Taxotere as an intravenous chemotherapy treatment for metastatic and adjuvant breast cancer. Its uses would eventually be expanded to include a range of cancers, including prostate, stomach, and head and nec, according to Salient News. Taxotere is administered every three weeks over the course of an hour, in the manner of traditional chemo treatments, and most patients undergo four cycles of Taxotere. Since being approved, more than 1.5 million patients have used Taxotere as a cancer treatment.

The lawsuit cited to a 2009 warning letter issued to the drug’s manufacturer by the FDA as a result of false or misleading statements about unsubstantiated claims of Taxotere®’s superior efficacy. According to the lawsuit, and as early as 2005, Sanofi-Aventis had knowledge based on their own study of Taxotere®’s increased risk of permanent baldness. The lawsuit alleges that despite this knowledge warnings of permanent alopecia in Canada and Europe, the drug’s U.S. label contained no mention of permanent hair loss until the label was changed in January 2016.

Taxotere® is widely prescribed for the treatment of early-stage breast cancer and other cancers. It is estimated that a majority of breast cancer patients receive Taxotere® as part of their chemotherapy regimen. According to the Susan G. Komen Foundation, nearly 250,000 cases of invasive breast cancer will be diagnosed in the U.S. in 2016.

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New Study to Investigate Long-Term Xarelto and Pradaxa Use

xarelto bleedingA patient-centered research institute is conducting two studies that will compare the effectiveness of Pradaxa, Xarelto and other oral blood thinners to determine what the long-term effects are.

The Patient-Centered Outcomes Research Institute (PCORI) announced the $6.5 million studies to scrutinize anticoagulants including:

  • Warfarin
  • Dabigatran (Pradaxa, made by Boehringer Ingelheim)
  • Rivaroxaban (Xarelto, made by Janssen)
  • Apixaban (Eliquis, made by Bristol-Myers Squibb)
  • Edoxaban (Savaysa, made by Daiichi Sankyo)

The drugs are used to to treat clots and are often used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

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Order Concerning Filing Fees When Filing Short Form Complaints in Zofran Litigation

zofranUS District Judge F. Dennis Saylor ordered on July 21 that any plaintiff in a pending action who previously filed a complaint and paid the filing fee, and who is adopting a version of the Short Form Complaint, need not pay the filing fee again. The order applies in In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts

The adoption of the Short Form Complaint is, in effect, the filing of an amended complaint, for which no additional fee is required. However, any plaintiff who files a new case directly in this MDL proceeding must pay the required filing fee. In other words, the filing of a new action requires the payment of filing fee, but such a fee need only be paid once.

Federal Judge F. Dennis Saylor IV on July 8, 2016 approved the new Short-Form Complaint and Jury Demand submitted by the parties in Zofran (Ondansetron) Products Liability Litigation.

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

In 2013, GSK made $12.8 billion in sales in the United States, making it the fifth most lucrative pharmaceutical company doing business in the United States according to IMS Health.

For more, read our article 260 Zofran Cases Filed Against GlaxoSmithKline and Zofran Litigation Update Defendants Summary Judgement Motion Denied

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IVC Filter Litigation Is the Hot, Trending Practice Area

Lawyer Troy Brenes
Troy Brenes

Litigation involving Cook and Cordis IVC Filters is now the hot, trending practice area for mass tort lawyers, with hundreds of cases already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

“These devices cause the one thing they are design to prevent —  blood clots,” says said Troy Brenes of Aliso Viejo, California, a lawyer who is active in IVC Filter litigation. “They cause the development and increase risk of thrombosis and pulmonary embolism.”

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

Brenes and John Dalimonte of Boston spoke on a recent webinar about the litigation sponsored by the Consumer Attorney Marketing Group. 

Plaintiff Numerosity

John Dalimonte
John Dalimonte

The number of potential plaintiffs is immense: Since 2000, Cook has sold 264,006 Tulip Filters and 129,089 Celect Filters. Attorneys Brenes and Dalimonte estimate that 200,000 Cordis filters have been inserted into patients.

Settlement values of the cases are unknown, and a settlement conference on June 7 with Cook “went nowhere.” The first bellwether trials are scheduled for next year.

IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.

However, Dalimonte identified three issues with the Cook Tulip and Celect IVC Filters:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.

Brenes and Dalimonte will be speaking at the upcoming AAJ annual convention, July 22-25 in Los Angeles. 

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3 State Attorneys General Charge that Volkswagen Scandal is 10-Year Orchestrated Fraud

NY, MD and MA AGs Sue Volkswagen
The lawsuits allege this cover-up was orchestrated at the highest levels of the company, up to and including the former CEO, Martin Winterkorn.

The Attorneys General for New York, Massachusetts and Maryland filed suit on July 19, 2016 against Volkswagen AG, Audi AG and Porsche AG, as well as their American subsidiaries, for the automakers’ sale of diesel cars that were fitted with illegal “defeat devices.”

These cars (including over 25,000 in New York, 15,000 in Massachusetts and 12,935 in Maryland) spewed illegal amounts of harmful emissions – and the companies attempting to cover-up their behavior.

Litigation against VW is consolidated in In re: Volkswagen “Clean Diesel” Litigation, MDL 2672. On August 25, 2016, attorneys may listen to a status conference by telephone using the CourtCall remote court appearance service. Advance registration for remote attendance is required; this can be done online or by calling CourtCall at (866) 582-6878.

Sample Motions and Forms are available online for subscribers of Mass Tort Nexus.

See our news story:
Shocker: EU Has Covered Up Volkswagen Emissions Cheating Since 2010
  • “The allegations against Volkswagen, Audi and Porsche reveal a culture of deeply-rooted corporate arrogance, combined with a conscious disregard for the rule of law and the protection of public health and the environment,” New York Attorney General Schneiderman said. “These suits should serve as a siren in every corporate board room, that if any company engages in this type of calculated and systematic illegality, we will bring the full force of the law—and seek the stiffest possible sanctions—to protect our citizens.”
  • “Volkswagen, Audi and Porsche defrauded thousands of Massachusetts consumers, polluted our air, and damaged our environment and then, to make matters worse, plotted a massive cover-up to mislead environmental regulators,” Massachusetts Attorney General Healey said. “With today’s action, we want to make clear to all auto manufacturers that violating laws designed to protect our environment and our public health is unacceptable and will be punished with significant penalties.”
  • “Maryland has worked tirelessly, through Maryland’s Healthy Air Act and Clean Cars Act, as well as stringent regulations adopted by the Department of the Environment, to clean our air,” said Maryland Attorney General Frosh. “As our complaint sets out, Volkswagen, Audi and Porsche installed defeat devices in their cars to trick regulators and to deceive the public; they did so knowing that their conduct was illegal and their misconduct has hindered our efforts to clean the air and to clean the Chesapeake Bay.  Their disregard for the health of our citizens and their disregard for our environment must be punished.”

10 Year Cover-Up

These lawsuits by the New York, Massachusetts and Maryland Attorneys General offices follow a nine-month long investigation by a multistate coalition of more than 40 states and other jurisdictions, led by New York, Massachusetts, and four other states.  New York State’s Department of Environmental Conservation, Massachusetts’s Department of Environmental Protection and Maryland’s Department of the Environment provided important assistance with the investigation.

The complaints allege, in detail, a cover-up that Volkswagen and Audi allegedly managed for nearly a year-and-a-half. The cover-up followed a study by researchers at West Virginia University that alerted authorities in this country that these diesel cars emitted much more nitrogen oxides (NOx) when driven on the road than they did when undergoing emissions testing on test equipment used by the U.S. Environmental Protection Agency (EPA) and the California Air Resource Board (CARB) to test the amount of air pollutants emitted by automobiles.

These suits follow the car companies’ partial settlements of claims for consumer relief and consumer deception penalties, as well as their agreement to establish a fund to mitigate the environmental damage caused by their admitted misconduct. Those earlier settlements did not resolve any of the claims for civil penalties that New York, Massachusetts and other states, as well as the EPA, may bring for the companies’ flagrant violations of state and federal environmental laws and regulations, nor did the settlements cover all of the vehicles equipped with emission control defeat devices.

Lies, Cover-up, Confession

The lawsuits allege that, after the EPA and CARB contacted Volkswagen and Audi about the discrepancies revealed by the West Virginia University study — which the companies fully knew were caused by their defeat devices – Audi and Volkswagen:

  • Tried to cover up the problem through sham recalls that they knew would not meet the required standards;
  • Repeatedly failed to disclose to regulators the true reason – the defeat devices – for the discrepancies; and
  • Only confessed to the defeat devices when they knew the regulators had them pinned to the facts.

The lawsuits allege this cover-up was orchestrated and approved at the highest levels of the company, up to and including the former CEO, Martin Winterkorn.

Throughout this entire course of alleged illegal conduct, where dozens of employees, officers and senior executives were involved, the investigation found no evidence that a single Volkswagen, Audi or Porsche employee came forward to blow the whistle.

As alleged in the complaints, Volkswagen’s response to the scandal shows that the company has not reformed its corporate behavior.  When the investigation was getting under way in late 2015, numerous employees, tipped off by a senior in-house lawyer in Germany, allegedly destroyed incriminating documents.  Just last month, the Volkswagen Supervisory Board recommended a package of bonuses for the Management Board that presided over the cover-up totaling over $70 million, including generous severance pay to Mr. Winterkorn himself. That recommendation was overwhelmingly approved by the company’s shareholders.

The Attorneys Generals’ investigation also found evidence that the misconduct of Volkswagen and its Audi and Porsche subsidiaries in the production and sale of these automobiles has few parallels in corporate history.

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Talcum Powder Plaintiff Seeks Centralization of Federal Ovarian Cancer Claims Against J&J

talcum powder cancer
By Sandy A. Liebhard, Bernstein Liebhard LLP, New York.

A talcum powder lawsuit plaintiff has filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to centralize all federal ovarian cancer claims in a single court for the purposes of coordinated pretrial proceedings.

According to a Motion for Transfer filed with the Panel on July 15, the plaintiff has suggested the U.S. District Court, Southern District of Illinois, as the most appropriate venue for the proposed multidistrict litigation. (Case Pending No. 70).

This court is the location of MDL 2385-Pradaxa (Dabigatran Etexilate) Products Liability Litigation in East St Louis, IL.

Read our hard-hitting report:

Behind the $55 Million Verdict: Johnson & Johnson Knew About Talcum Powder Cancer Risks Since the 1970s

Court records show that at least 11 product liability claims involving talcum powder and ovarian cancer have already been filed in 10 federal jurisdictions. Among other things, the motion points out that the current plaintiffs reside in several different states, and it asserts that the Southern District of Illinois “would permit convenient travel for the parties and counsel as compared to travel to the East or West Coast.”

More than 1,200 talcum powder lawsuits have been filed against Johnson & Johnson nationwide, with litigation already underway in St. Louis, Missouri and New Jersey Superior Court. The federal docket also has the potential to be large, and would likely benefit from centralization, as coordinated pretrial proceedings would eliminate duplicative discovery and inconsistent court rulings.

Talcum Powder Ovarian Cancer Litigation

All the talcum powder lawsuits currently pending in federal courts similarly allege that regular, repeated application of Johnson & Johnson’s Baby Powder and Shower-to-Shower products to the genitals can increase a woman’s risk for ovarian cancer.

The complaints charge that talc particles can make their way into the vagina and migrate to the ovaries when used in this way. Over time, the accumulating talc can result in the type of inflammation that promotes the growth of cancer cells. While a number of studies published since the 1970s have suggested such a link, plaintiffs claim that Johnson & Johnson has failed to take any steps to warn women of this possible risk.

In April, a St. Louis jury awarded $55 million in compensatory and punitive damages to an ovarian cancer victim who used Johnson & Johnson’s talc-based powders for nearly 40 years as part of her feminine hygiene routine. In February, another Missouri trial ended with an award of $72 million for the family of a woman who died from the disease after using the company’s talc products for more than 30 years. (Case No. 1422-CC09012-01)

Follow our continuing coverage:

Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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Shocker: EU Has Covered Up Volkswagen Emissions Cheating Since 2010

VW-Emissions-300x200For the last six years, the European Commission has known that German automaker Volkswagen was cheating on emissions of its diesel vehicles, according to Spiegel Online.

  • The emissions cheating had been under discussion for years both within the Commission and the EU member governments.
  • The German government was notified about a 2012 meeting about the corporate deception.
Read our latest story: 3 State Attorneys General Charge that Volkswagen Scandal is 10-Year Orchestrated Fraud

The scandal first made headlines in 2015 when it became known that Volkswagen had manipulated the emissions of its diesel vehicle, but the cover up was just revealed today.

Litigation against VW is consolidated in In re: Volkswagen “Clean Diesel” Litigation, MDL 2672. On August 25, 2016, attorneys may listen to a status conference by telephone using the CourtCall remote court appearance service. Advance registration for remote attendance is required; this can be done online or by calling CourtCall at (866) 582-6878.

Sample Motions and Forms are available online for subscribers of Mass Tort Nexus.

EU knew about defeat devices

In the middle of the 2000s, European Commission experts noticed an odd phenomenon: Air quality in European cities was improving much more slowly than expected in light of stricter emissions regulations. It charged the Joint Research Centre (JRC) — an organization that carries out studies on behalf of the Commission — with measuring emissions in real-life conditions.

On October 8, 2010 — roughly three years after the JRC air quality tests — an internal memo noted that it was “well known” that there was a discrepancy between diesel vehicle emissions during the approval stage of new vehicle models and real-world driving conditions. The documents also makes the origin of this discrepancy clear: It is the product of “defeat devices” — essentially programs in the engine software — that would shut off anti-pollution controls, according to Spiegel Online.

On June 28, 2016, in settlements with the Department of Justice, the State of California, and the U.S. Federal Trade Commission (FTC), Volkswagen AG agreed to pay up to $14.7 billion to settle allegations of cheating emissions tests and deceiving customers. Volkswagen will offer consumers a buyback and lease termination for nearly 500,000 model year 2009-2015 2.0 liter diesel vehicles sold or leased in the U.S., and spend up to $10.03 billion to compensate consumers under the program. In addition, the company will spend $4.7 billion to mitigate the pollution from these cars and invest in green vehicle technology.

 

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